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Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit(Fluorescence PCR)

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Category:Respiratory tract infection

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Freeze-dried Mycobacterium Tuberculosis DNA Detection Kit(Fluorescence PCR)

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Introduction

[Product Name]

Freeze-dried Mycobacterium Tuberculosis DNA Detection KitFluorescence PCR

 

[Packaging Size]

20 tests/kit, 50 tests/kit

 

[Intended Use]

It is suitable for qualitative detection of Mycobacterium tuberculosis DNA in human clinical sputum samples, and is suitable for auxiliary diagnosis of Mycobacterium tuberculosis infection. The test results are for clinical reference only, and the final diagnosis should be comprehensively considered in close combination with other clinical indicators.

Mycobacterium culosis, referred to as Tubercle bacillus(TB), is a class of obligate aerobic bacteria with positive acid-fast staining. It is amastigote and has fimbriae and microcapsules but not forms spores. Its bacterial wall has neither teichoic acid of gram-positive bacteria, nor lipopolysaccharide of gram-negative bacteria. Mycobacterium tuberculosis, which is pathogenic to humans, is generally considered to be human, bovine, and African. Its pathogenicity may be related to the inflammation caused by the proliferation of bacteria in tissue cells, the toxicity of bacterial components and metabolites, and the immune damage to the bacterial components. Pathogenic substances are associated with capsules, lipids and proteins. Mycobacterium tuberculosis can invade susceptible organisms through the respiratory tract, digestive tract or skin injury, causing tuberculosis of various tissues and organs, of which the most common is pulmonary tuberculosis through the respiratory tract. It usually occurs in children, and presents with symptoms such as low-grade fever, night sweats, and a small amount of hemoptysis. Secondary infection is mainly manifested as low-grade fever, night sweats, and hemoptysis. Mostly it is long-term chronic disease, and a few are acute. Tuberculosis is one of the top ten causes of human death worldwide. In 2018, about 10 million people around the world were infected with Mycobacterium tuberculosis, of which about 1.6 million died. 

IS6110 is an inserted nucleotide sequence discovered by Thierry et al. in 1990 in Mycobacterium tuberculosis. IS6110 is present in multiple copies of a sequence in the Mycobacterium tuberculosis, Mycobacterium africanum, Mycobacterium bovis, and BCG genes. IS6110 is relatively stable in the strains in which it exists, and will not change the IS6110 DNA fingerprints when the strains develop drug-resistant mutations. The 38KD protein antigen is a phosphate transporter and contains 6 epitopes targeted by monoclonal antibodies specific for Mycobacterium tuberculosis. The diagnostic specificity of the reported 38KD is 88%-100%.

 

[Main Components]

 

S/N

Component(20 tests/kit)

Character

Strength

Component Description

1

TB Reaction Buffer

freeze-dried      

1 bottle

Contains Mycobacterium tuberculosis IS6110 and 38KD, internal control specific primers, fluorescent probes, Taq enzyme, UDG enzyme, reaction buffer, etc.

2

TB Positive Control

freeze-dried

1 vial

Contains IS6110, 38KD and internal control mixed plasmid diluent

3

TB Blank Control

liquid

1 vial, 600μL/vial

DNase/RNase free H2O

4

Reconstituted Solution

liquid

1 vial, 1mL/vial

DNase/RNase free H2O,etc.

 

S/N

Component(50 tests/kit)

Character

Strength

Component Description

1

TB Reaction Buffer

freeze-dried         

1 bottle

Contains Mycobacterium tuberculosis IS6110 and 38KD, internal control specific primers, fluorescent probes, Taq enzyme, UDG enzyme, reaction buffer, etc.

2

TB Positive Control

freeze-dried

1 vial

Contains IS6110, 38KD and internal control mixed plasmid diluent

3

TB Blank Control

liquid

1 vial, 600μL/vial

DNase/RNase free H2O

4

Reconstituted Solution

liquid

1 vial, 1.45mL/vial

DNase/RNase free H2O, etc.

 

Note: Components of different batches cannot be mixed or interchanged.

 

[Storage Conditions and Shelf-life]

  1. Unopened kit: It should be stored at no higher than 30℃ and protected from light, and the shelf-life is 12 months.

2. After opening the sealed bag, the lyophilized reagent in the tube should be used immediately.

3. RT-PCR detection should be performed immediately after reconstitution of the lyophilized nucleic acid reaction buffer, otherwise it should be stored at -25℃ to -15℃ and protected from light. The validity period is 1 week, and repeated freezing and thawing should be avoided ( limited to 2 cycles).

4.After reconstituting the lyophilized positive control, it should be stored at -25°C to -15°C. The validity period is 1 week, and repeated freezing and thawing should be avoided (limited to 2 cycles).

5.Transportation conditions: It can be transported stably for 1 month when the temperature is not higher than 37℃.

6. See the packaging label for the production date, production batch number and expiration date.

 

[Applicable Instruments]

Applied Biosystems 7500 Real-Time PCR Systems, Applied Biosystems 7500 Fast Real-Time PCR Systems, QuantStudio®5 Real-Time PCR Systems, SLAN-96P Real-Time PCR Systems(Shanghai Hongshi Medical Technology Co., Ltd. ), LightCycler®480 Real-Time PCR system, LineGene 9600 Plus Real-Time PCR Detection SystemFQD-96ABioer technology), MA-6000 Real-Time Quantitative Thermal Cycler (Suzhou Molarray Co., Ltd.) , BioRad CFX96 Real-Time PCR System, BioRad CFX Opus 96 Real-Time PCR System.

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